Pharmacokinetics Clinical Trial
Official title:
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults
This study is being done to determine the systemic absorption of nasally inhaled acetaminophen (Tylenol®) versus orally ingested acetaminophen by comparing the serum drug concentrations of the two groups obtained at various times after study drug administration.
This study is aimed at addressing a significant void in the current literature regarding
nasally administered acetaminophen pharmacokinetics. The pharmacokinetics of acetaminophen
following oral and rectal administration have been well studied but to date there are no
published studies determining the pharmacokinetics of acetaminophen following intranasal
administration. This route is currently popular among heroin users. Understanding the
pharmacokinetics of nasally administered acetaminophen will help physicians address the
important clinical implications of acetaminophen toxicity in this population.
Ten healthy adult volunteers age 18 to 45 years will be recruited for this pilot project.
Study participants will be randomized in permuted blocks to receive either oral or intranasal
administration of a standardized 500 mg dose of acetaminophen. Blood samples will be drawn
from a peripheral intravenous catheter at 0, 5, 15, 30, 45, 60, 90, 120, 150, 240, 360, and
480 minutes after study drug administration and sent to the laboratory for determination of
serum acetaminophen concentration. After a one week washout period, each participant will
cross over to receive 500 mg of acetaminophen via the remaining route of administration in
the second arm of the study. The serial acetaminophen concentrations will be utilized to
perform pharmacokinetic calculations.
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